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ISTODAX is a brand name for Romidepsin, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ISTODAX® (romidepsin for injection) is indicated for: • the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy. Approval is based on response rates demonstrated in a single-arm trial (see 14 CLINICAL…
Verbatim from this product's HC label. Tap a section to expand.
Romidepsin treatment should only be administered under the supervision of a physician qualified in the use of chemotherapeutic agents and administration should be confined to units specialized in the use of cytotoxic chemotherapy. 1 Dosing Considerations • ISTODAX (romidepsin for injection) is moderately emetogenic.
Antiemetics were commonly used in clinical trials involving ISTODAX. Premedication with antiemetics is recommended. • Serum potassium and magnesium should be within the normal range before each administration of ISTODAX. 9% Sodium Chloride, USP.
• ISTODAX has not been studied in patients with end stage renal function. • Dosage given should be adjusted according to tolerability as described below. 2 Recommended Dose and Dosage Adjustment The recommended dose is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8 and 15 of a 28-day cycle.
Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the therapy.
Dose Modifications:
Nonhematologic toxicities except alopecia • Grade 2 or 3 toxicity: Treatment with ISTODAX should be delayed until toxicity returns to ≤ Grade 1 or baseline, then therapy may be restarted at 14 mg/m2. If Grade 3 toxicity recurs, treatment with ISTODAX should be delayed until toxicity returns to ≤ Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2.
• Grade 4 toxicity: Treatment with ISTODAX should be delayed until toxicity returns to ≤ Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2. • ISTODAX should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.
5×109/L and/or platelet count ≥75×109/L or baseline, then therapy may be restarted at 14 mg/m2. 5ºC) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with ISTODAX should be delayed until the specific cytopenia returns to ≤ Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m2.
Pediatrics • The safety and effectiveness of ISTODAX has not been evaluated in pediatric patients (age <18). Geriatrics • The safety and effectiveness of ISTODAX has not been evaluated in elderly patients (age >65). Elderly patients may experience greater sensitivity to treatments with ISTODAX and may require dose modifications.
) • QT interval prolongation (see 7 WARNINGS AND PRECAUTIONS) • Fatal infections (see 7 WARNINGS AND PRECAUTIONS) ISTODAX (romidepsin) Page 6 of 40 • Tumor lysis syndrome (see 7 WARNINGS AND PRECAUTIONS) • Potential fetal harm (see 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY) • Hepatic impairment (see 7 WARNINGS AND PRECAUTIONS Special Populations) ISTODAX has not been studied in patients with renal impairment.
• Available only under the Restricted Access Program (see 1 INDICATIONS, Distribution Restriction) 4 DOSAGE AND ADMINISTRATION Romidepsin treatment should only be administered under the supervision of a physician qualified in the use of chemotherapeutic agents and administration should be confined to units specialized in the use of cytotoxic chemotherapy.
1 Dosing Considerations • ISTODAX (romidepsin for injection) is moderately emetogenic. Antiemetics were commonly used in clinical trials involving ISTODAX. Premedication with antiemetics is recommended. • Serum potassium and magnesium should be within the normal range before each administration of ISTODAX.
9% Sodium Chloride, USP. • ISTODAX has not been studied in patients with end stage renal function. • Dosage given should be adjusted according to tolerability as described below. 2 Recommended Dose and Dosage Adjustment The recommended dose is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8 and 15 of a 28-day cycle.
Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the therapy.
Dose Modifications:
Nonhematologic toxicities except alopecia • Grade 2 or 3 toxicity: Treatment with ISTODAX should be delayed until toxicity returns to ≤ Grade 1 or baseline, then therapy may be restarted at 14 mg/m2. If Grade 3 toxicity recurs, treatment with ISTODAX should be delayed until toxicity returns to ≤ Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2.
• ISTODAX is contraindicated in patients who are hypersensitive to romidepsin or to any ingredient in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatic Impairment • The use of ISTODAX is not recommended in patients with severe hepatic impairment (bilirubin level > 3 x upper limit normal (ULN) and any AST) (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, 7 WARNINGS AND PRECAUTIONS, Special Populations, Hepatic Impairment).
5 x ULN to ≤ 3 x ULN, and any AST), reduce the starting dose of ISTODAX to 7 mg/m2 (50% reduction) (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Hepatic Impairment). 5 x ULN, and any AST) (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
• The risk of adverse effects associated with ISTODAX may be increased in patients with hepatic impairment. Monitor patients for signs of toxicity (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). Renal Impairment • No dedicated studies with ISTODAX in patients with impaired renal function have been carried out therefore there is no available data regarding recommendations for dose adjustment (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency).
3 Reconstitution ISTODAX (romidepsin for injection) should be handled in a manner consistent with recommended safe procedures for handling cytotoxic drugs. 9% Sodium Chloride Injection, USP before intravenous infusion. 4 mL of diluent).
2 mL overfill. 2 mL from the supplied diluent vial, and slowly inject it into the ISTODAX vial for injection. Swirl the contents of the vial until there are no visible particles in the resulting solution. The reconstituted solution will contain ISTODAX 5 mg/mL.
• Extract the appropriate amount of ISTODAX from the vials to deliver the desired dose, using proper aseptic technique. 9% Sodium Chloride Injection, USP. 4 Administration Infuse over 4 hours. Stability and Compatibility ISTODAX should be prepared immediately before use and the reconstituted and diluted solution should be administered as soon as possible.
The reconstituted ISTODAX solution is chemically stable for up to 8 hours at room temperature. The diluted solution is compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), polyethylene (PE) infusion bags as well as glass bottles, and is chemically stable for up to 24 hours when stored at room temperature.
However, it should be administered as soon after dilution as possible. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container […]
• Grade 4 toxicity: Treatment with ISTODAX should be delayed until toxicity returns to ≤ Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2. • ISTODAX should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.
5×109/L and/or platelet count ≥75×109/L or baseline, then therapy may be restarted at 14 mg/m2. 5ºC) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with ISTODAX should be delayed until the specific cytopenia returns to ≤ Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m2.
Pediatrics • The safety and effectiveness of ISTODAX has not been evaluated in pediatric patients (age <18). Geriatrics • The safety and effectiveness of ISTODAX has not been evaluated in elderly patients (age >65). Elderly patients may experience greater sensitivity to treatments with ISTODAX and may require dose modifications.
Hepatic Impairment • The use of ISTODAX is not recommended in patients with severe hepatic impairment (bilirubin level > 3 x upper limit normal (ULN) and any AST) (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, 7 WARNINGS AND PRECAUTIONS, Special Populations, Hepatic Impairment).
5 x ULN to ≤ 3 x ULN, and any AST), reduce the starting dose of ISTODAX to 7 mg/m2 (50% reduction) (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Hepatic Impairment). 5 x ULN, and any AST) (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
• The risk of adverse effects associated with ISTODAX may be increased in patients with hepatic impairment. Monitor patients for signs of toxicity (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). Renal Impairment • No dedicated studies with ISTODAX in patients with impaired renal function have been carried out therefore there is no available data regarding recommendations for dose adjustment (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency).
3 Reconstitution ISTODAX (romidepsin for injection) should be handled in a manner consistent with recommended safe procedures for handling cytotoxic drugs. 9% Sodium Chloride Injection, USP before intravenous infusion. 4 mL of diluent).
2 mL overfill. 2 mL from the supplied diluent vial, and slowly inject it into the ISTODAX vial for injection. Swirl the contents of the vial until there are no visible particles in the resulting solution. The reconstituted solution will contain ISTODAX 5 mg/mL.
• Extract the appropriate amount of ISTODAX from the vials to deliver the desired dose, using proper aseptic technique. 9% Sodium Chloride Injection, USP. 4 Administration Infuse over 4 hours. Stability and Compatibility ISTODAX should be prepared immediately before use and the reconstituted and diluted solution should be administered as soon as […]